510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 3078 of 3528

510(k) clearances, page 3078 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841326	Replace-a-Tip Rechargeable High Temp	Suncoast Medical Manufacturers, Inc.	HQP	Class II	1984-05-09
K841325	Replace-a-Tip Recharg. Low Temp.	Suncoast Medical Manufacturers, Inc.	HQP	Class II	1984-05-09
K841293	Panoramic Loupes - Various	Keller Instruments, Inc.	HLT	Class II	1984-05-09
K841292	Spectacle Indirect Ophthalmoscope	Keller Instruments, Inc.	HLJ	Class II	1984-05-09
K841182	Multiple Chem. Module for Analysis	Beckman Instruments, Inc.	CHH	Class I	1984-05-09
K841181	Astra Sys Inorganic Phosphorus Chem	Beckman Instruments, Inc.	CEO	Class I	1984-05-09
K841168	Sterilization Process Indicator	Parke-Davis Co.	JOJ	Class II	1984-05-09
K841116	Mobile Ophthalmic Operating Table	Surgi-Quip Inc.U	FWX	Class I	1984-05-09
K841115	Charles/mcintyre Giant Break Table	Surgi-Quip Inc.U	FQO	Class I	1984-05-09
K841024	Ventrezyme T4u Immunoassay T4u	Ventrex Laboratories, Inc.	CEE	Class II	1984-05-09
K841007	Ophthalmic Curette-Various	Premier Dental Products Co	HNZ	Class I	1984-05-09
K841002	Lachrymal Probes-Various	Premier Dental Products Co	HNW	Class I	1984-05-09
K840965	Site Coaxial I/a Handpiece 30 Tip	Chiron Vision Corp.	HQC	Class II	1984-05-09
K840861	Tse-Anderson Modified Lacrimal Groov	Hansen Ophthalmic Development Lab	HNL	Class I	1984-05-09
K840855	Corneal Scleral Lance	Sharpoint, Inc.	HNN	Class I	1984-05-09
K840694	Lens Insertion Glide	Innovative Surgical Products, Inc.	KYB	Class I	1984-05-09
K840590	Fleischman-Swartz Endo-Ocular Probe	Hgm, Inc.	HQF	Class II	1984-05-09
K840540	Technicare Model 330	Technicare Corp.	IYO	Class II	1984-05-09
K840492	Sun-Lite Blue Slit	Suncoast Medical Manufacturers, Inc.	HTP	Class I	1984-05-09
K840451	Biopsy Attachment;dynex Ultrasound-	Elscint, Inc.	IYO	Class II	1984-05-09
K840430	Sun-Lite White Slit	Suncoast Medical Manufacturers, Inc.			1984-05-09
K840428	Sun-Lite Pen Light	Suncoast Medical Manufacturers, Inc.			1984-05-09
K840427	Sun-Lite Blue Spot	Suncoast Medical Manufacturers, Inc.			1984-05-09
K840426	Optherm Extra Fine Tip	Suncoast Medical Manufacturers, Inc.	HQP	Class II	1984-05-09
K840425	Optherm Fine Tip	Suncoast Medical Manufacturers, Inc.	HQP	Class II	1984-05-09
K840402	Audio Bandwidth Analyzer	D. E. Hokanson, Inc.	IYN	Class II	1984-05-09
K840311	Cat. 7-Ear, Nose & Throat Devices	Imm Enterprises, Ltd.	KCP	Class I	1984-05-09
K840285	Non Stress Test Monitor 507	Imex Medical Systems, Inc.	HGH	Class II	1984-05-09
K840228	Healthcheck Auto Inflate Digital Bp	Timex Medical Products Corp.	DXN	Class II	1984-05-09
K840139	Irex 720 Sector Scanner	Irex Corp.	IYO	Class II	1984-05-09
K834602	Switching Unit Electrode Catheter	Webster Laboratories, Inc.	DRF	Class II	1984-05-09
K834284	Ultrasound Scanner 501	Imex Medical Systems, Inc.	IYO	Class II	1984-05-09
K834034	Modem Accessory for Epi Cardia Sys	Medicomp, Inc.	DXH	Class II	1984-05-09
K833973	Minolta Sm-32 Oxygen Saturation Monit	Marquest Medical Products, Inc.	DQA	Class II	1984-05-09
K833951	E 310 Electrocardiograph	Burdick Corp.	DPS	Class II	1984-05-09
K833819	M305	Burkick Corp.	DXJ	Class II	1984-05-09
K833747	Gallie Cryonucleator	Mono Research Laboratories	HPS	Class II	1984-05-09
K833705	Betaject Bd U100	Orange Medical Instruments, Inc.	FMI	Class II	1984-05-09
K833667	Diasonics Dla-100	Diasonics, Inc.	IYO	Class II	1984-05-09
K833656	Narcotrace 40 - Nt40	Narco Bio-Systems	DSF	Class I	1984-05-09
K833593	Fukuda Denshi Fx-102 Auto-Single Chan	Brentwood Instruments, Inc.	DPS	Class II	1984-05-09
K833223	Sonel 3000A	Cgr Medical Corp.	IYO	Class II	1984-05-09
K832828	Centurion Cardiac Detector	Clinical Data Instruments, Inc.	DRJ	Class I	1984-05-09
K832429	Cardio Trace Electrode	Poly-Med Splint Co.	DRX	Class II	1984-05-09
K841754	Columbia Cna Agar	The Montana Deaconess Medical Center	JSJ	Class I	1984-05-07
K841711	Mac Lee Sitz Bath	Mac Lee Medical Products	KTC	Class I	1984-05-07
K841666	Rabbit Kidney Cells	Viromed Laboratories, Inc.	KIR	Class I	1984-05-07
K841665	Rhesus Sv5/sv40	Viromed Laboratories, Inc.	KIR	Class I	1984-05-07
K841578	Disposable Syringe	Ava Medical Products of Canada, Inc.	FMF	Class II	1984-05-07
K841577	Hypodermic Needles	Ava Medical Products of Canada, Inc.	FMI	Class II	1984-05-07